Efficacy and Safety of Prescription Omega-3 Fatty Acids for the Prevention of Recurrent Symptomatic Atrial Fibrillation A Randomized Controlled Trial
Efficacy and Safety of Prescription Omega-3 Fatty Acids for the Prevention of Recurrent Symptomatic Atrial Fibrillation A Randomized Controlled Trial
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DOI：
10.1001/jama.2010.1735
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发表时间：
2010-12-01
影响因子：
120.7
通讯作者：
Pratt, Craig M.
中科院分区：
文献类型：
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作者：
Kowey, Peter R.;Reiffel, James A.;Pratt, Craig M.
背景心房颤动(房颤)很常见，但对其他治疗方案的医疗需求仍未得到满足。目前的药物治疗效果有限，不良反应严重。来自小型试验的有限数据表明，omega-3多不饱和脂肪酸可能为房颤患者提供安全、有效的治疗选择。目的评价处方omega-3脂肪酸(处方omega-3)预防复发症状性房颤的安全性和有效性。设计、设置和参与者前瞻性、随机、双盲、安慰剂对照、平行分组多中心试验，涉及663名美国门诊参与者，确诊为症状性阵发性房颤(n=542)或持续性房颤(n=121)，无实质性结构性心脏病，从2006年11月至2009年7月(最后一次随访是2010年1月)收集基线时窦性心律正常的患者。干预：前7天服用omega-3(8g/d)或安慰剂；处方omega-3(4g/d)或安慰剂，此后至24周。主要观察指标：主要终点是阵发性房颤参与者的症状性房颤复发(首次复发)。二次分析包括顽固层和两层合并的首次复发。结果在24周时，在阵发性房颤层，安慰剂组269名参与者中129名(48%)和处方组258名参与者中135名(52%)出现反复的症状性房颤或扑动事件。在持续性房颤组中，安慰剂组有18人(33%)和处方组有32人(50%)有症状房颤或扑动事件的记录。在阵发性阵发性房颤(HR)、持续性阵发性房颤(HR)、持续性房颤(HR)和两层合并症(HR，1.22；95%CI，0.98~1.52；P=0.08)中，治疗组与对照组相比无显著差异(HR为1.15；95%可信区间为0.90~1.46；P=0.26)。其他次要终点支持初步结果。总共有5%的服用安慰剂的人和4%的服用omega-3处方药的人因不良事件而停用。在第4周和第24周，处方组的二十碳五烯酸和二十二碳六烯酸的血液水平显著高于安慰剂组。结论在阵发性房颤的参与者中，与安慰剂相比，处方omega-3治疗24周并不能减少6个月后的房颤复发。
Context Atrial fibrillation (AF) is common, yet there remains an unmet medical need for additional treatment options. Current pharmacological treatments have limited efficacy and significant adverse events. Limited data from small trials suggest omega-3 polyunsaturated fatty acids may provide a safe, effective treatment option for AF patients.Objective To evaluate the safety and efficacy of prescription omega-3 fatty acids (prescription omega-3) for the prevention of recurrent symptomatic AF.Design, Setting, and Participants Prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter trial involving 663 US outpatient participants with confirmed symptomatic paroxysmal (n=542) or persistent (n=121) AF, with no substantial structural heart disease, and in normal sinus rhythm at baseline were recruited from November 2006 to July 2009 (final follow-up was January 2010).Interventions Prescription omega-3 (8 g/d) or placebo for the first 7 days; prescription omega-3 (4 g/d) or placebo thereafter through week 24.Main Outcome Measures The primary end point was symptomatic recurrence of AF (first recurrence) in participants with paroxysmal AF. Secondary analyses included first recurrence in the persistent stratum and both strata combined. Participants were followed up for 6 months.Results At 24 weeks, in the paroxysmal AF stratum, 129 of 269 participants (48%) in the placebo group and 135 of 258 participants (52%) in the prescription group had a recurrent symptomatic AF or flutter event. In the persistent AF stratum, 18 participants (33%) in the placebo group and 32 (50%) in the prescription group had documented symptomatic AF or flutter events. There was no difference between treatment groups for recurrence of symptomatic AF in the paroxysmal stratum (hazard ratio [HR], 1.15; 95% confidence interval [CI], 0.90-1.46; P=.26), in the persistent stratum (HR, 1.64; 95% CI, 0.92-2.92; P=.09), and both strata combined (HR, 1.22; 95% CI, 0.98-1.52; P=.08). Other, secondary end points were supportive of the primary result. A total of 5% of those receiving placebo and 4% of those receiving prescription omega-3 discontinued due to adverse events. Eicosapentaenoic and docosahexaenoic acid blood levels were significantly higher in the prescription group than in the placebo group at weeks 4 and 24.Conclusion Among participants with paroxysmal AF, 24-week treatment with prescription omega-3 compared with placebo did not reduce recurrent AF over 6 months.